The U.S. Food and Drug Administration approved the Zilver PTX Drug-Eluting Peripheral Stent (Zilver PTX Stent), the first drug-eluting stent indicated to re-open a particular artery in the thigh (femoropopliteal artery) when narrowed or blocked as a result of peripheral artery disease (PAD). PAD occurs when fatty material (plaque) builds up in the arteries that carry blood to the head, organs and limbs, usually affecting the arteries in the legs. This causes hardening and/or narrowing of the arteries (atherosclerosis), limiting the flow of oxygen-rich blood to the body. People with PAD may experience lifestyle-limiting symptoms, such as leg pain, or serious complications, including skin ulcers or gangrene. The Zilver PTX Stent includes a small, metal mesh tube called a self-expanding metal stent that keeps an artery open. The stent is coated on its outer surface with the drug paclitaxel, a drug that helps prevent recurrent narrowing of arteries (restenosis). Existing options for treatment of PAD can include exercise, drug therapy, and other options within the artery, such as percutaneous transluminal angioplasty (PTA, or balloon angioplasty), or bare-metal stenting or surgical bypass.
"The clinical study demonstrated that the Zilver is more effective than balloon angioplasty for the treatment of symptomatic peripheral artery disease in above-the-knee femoropopliteal artery," said Christy Foreman, director of the Office of Device Evaluation at FDA's Center for Devices and Radiological Health.
"This approval expands the treatment options for patients suffering from symptomatic peripheral artery disease to include the Cook Zilver PTX drug eluting stent." Data supporting the safety and effectiveness of the stent came from extensive non-clinical testing including biocompatibility, bench, and animal testing, as well as a clinical trial program. One clinical trial compared the safety and effectiveness of the Zilver PTX stent to PTA and bare-metal stenting. This study enrolled 479 patients with a single stenotic lesion less than 140 mm long in one or both of their femoropopliteal arteries. Patients randomly received the Zilver PTX or underwent PTA. If PTA failed, the patient then randomly received either a Zilver PTX or a bare metal stent that did not have the paclitaxel coating.